Carestream Health said today it filed a 510(k) application with the FDA seeking clearance for its OnSight 3D Extremity System cone-beam based extremity CT imaging device. The Rochester, N.Y.-based company’s system is designed to provide high-quality, low-dose 3D imaging for use by orthopedic and sports medicine practices, hospitals, imaging centers, urgent care facilities and other healthcare […]
Food & Drug Administration (FDA)
Xeltis wins FDA nod for bioresorbable pulmonary valve
Xeltis said yesterday that the FDA designated the bioresorbable replacement pulmonary valve it’s developing as a humanitarian use device, granted for device designed to treat rare diseases. The Swiss medical device company’s technology is designed to promote endogenous tissue restoration using polymers structured as a resorbable “porous matrix.” The aim is to gradually replace the polymer structure […]
Intersect ENT wins expanded FDA approval for Propel Mini
Intersect ENT (NSDQ:XENT) said today it won FDA premarket approval for an expanded indication for its Propel mini steroid releasing sinus implant designed to treat patients undergoing frontal sinus surgery. The expanded indication from the Menlo Park, Calif.-based company will allow the company to market the placement of the Propel mini in the frontal sinuses […]
ACell wins 510(k) for modified MicroMatrix
ACell said today it won additional FDA 510(k) clearance for its MicroMatrix device allowing the use of the device in conjunction with Cytal wound matrix or Cytal burn matrix devices. The MicroMatrix is a micronized particulate form of ACell’s Urinary Bladder Matrix designed to cover the wound bed in normal or irregular wounds, the Columbia, […]
FDA OKs improved MarginProbe device from Dune Medical
Dune Medical Devices said today it won pre-market approval from the FDA for modifications to its MarginProbe breast cancer surgical device designed for real-time detection of cancer in breast conserving surgeries. Modifications to the Paoli, Penn.-based company’s device were made to conform to recent changes in the European Union’s Restriction of Hazardous Substances requirements, Dune […]
FDA clears Stimwave’s StimQ wireless chronic pain stimulator
Stimwave Technologies said today that it’s putting its StimQ peripheral nerve stimulator on the U.S. market after winning pre-market approval from the FDA earlier this month. The StimQ device is designed to treat severe, intractable chronic pain in peripheral nerves, according to Ft. Lauderdale-based-based Stimwave. The tiny device, which is less than 5% of the size […]
FDA warns Terumo over vascular sheath
The FDA last week sent a warning letter to Terumo Corp. (TYO:4543) over issues with the manufacturing and quality control of its Destination Guiding vascular sheaths. The agency warned the company over issues with the manufacturing, packing, storage and installation at the facility that produces its Destination sheaths, referencing failures around design and conformity. The […]
Abiomed, FDA come to terms on Impella PMA requirements
Abiomed (NSDQ:ABMD) said yesterday that it came to terms with the FDA over the indications for use for its Impella line of cardiac assist devices and doesn’t believe it will have to appear before 1 of the agency’s advisory panels. Danvers, Mass.-based Abiomed said the federal safety watchdog agreed on the indication for treating patients in […]
FDA proposes ban on powdered medical gloves
The FDA today unveiled a proposal to ban most powdered medical gloves in the U.S. The agency said that while the use of such gloves is decreasing, they still pose an unreasonable and substantial risk of illness or injury to both providers and patients, as well as other individuals who are exposed to them. The […]
Repro-Med updates on FDA warning letter over Freedom Infusion sets
Repro-Med Systems last Friday updated on a warning letter it received in February over issues the FDA found with the company’s Freedom 60 syringe infusion pump and Freedom Edge infusion pumps. The company said it submitted a response to the warning letter last Friday to the FDA, 3 days before the required response date set by […]
FDA weighs dangers of faulty readings from blood clot monitors
The FDA is considering possible dangers from medical devices that monitor blood clotting producing false readings, according to a report from The Wall Street Journal. The FDA has tracked thousands of cases of malfunctions from such devices over the years, the WSJ reports. Deaths and serious injuries have been linked with the erroneous readings, due […]